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Job Description: POSITION SUMMARY
Summarize the primary purpose & key accountabilities of the position, including scope of responsibility in 5-7 concise sentences. (It may be helpful to complete this section after you have finished the other sections of the document.
• Differentiated Drug Delivery (DDD) is a drug device combination design and development organization focused on improving patients’ lives through customer-focused innovation and broad-based access to quality medicines and products. Supporting the Pharmaceutical Essential Health business unit (formerly Pharmaceutical’s Global Established Pharmaceutical (GEP) organization) specifically sterile injectables product, the Systems Engineering function has the primary responsibility for developing Design History File (DHF) documentation for ensuring compliance to CFR 820.30 Design Controls and risk management per ISO 14971 for the device constituent and drug-device interfaces of combination products. The Systems Engineering team owns deliverables that document safety and efficacy for new product submissions and also provide for post-market risk assessment and change control. The Systems Engineering function has primary responsibility for developing Design History File (DHF) documentation for ensuring compliance to CFR 820.30 Design Controls and risk management per ISO 14971 for the device constituent and drug-device interfaces of combination products. The Systems Engineering team owns deliverables that document safety and efficacy for new product submissions and also post-market maintenance activities such as risk assessment, change management, and technical support for regulatory inquiries.
• This position is responsible for end-to-end product life cycle management including project planning, creating and maintaining product requirements and risk files, establishing and publishing traceability, and providing for on-market support and maintenance. In compliance with CFR 820 and corporate procedures, this position will be responsible for documentation generated in support of product development and submissions, and may also be responsible for on-market product documentation.
In order of importance, list the primary responsibilities critical to the performance of the position. Please include actual tasks and/or essential responsibilities that highlight accountability and level of judgment required.
• Determines the DHF Structure and Owns the Requirements and Risk Management File. Primary responsibility for DHF content generation in support of regulatory submissions with compliance to governing procedures and CFR 820.30. Partner with other functions in the organization to ensure stakeholders' requirements are addressed and met as appropriate; to provide consistent direction to cross functional teams and to instill a spirit of collaboration throughout the organization.
• Integrates multiple approaches to solve problems or optimize solutions in cross functional manufacturing processes or product designs. Creates/modifies subsystems' designs. Integrates subsystems and components in total systems designs; develops specifications from customer requirements.
Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.
As a member of Systems & Risks in R&D, this person will collaborate and participate in cross functional teams working closely with Program Management, Quality, Regulatory, Design and Development, Medical Safety, Marketing, Clinical, Manufacturing, Biocompatibility to complete project deliverables relating to Systems and Risks.
EDUCATION AND EXPERIENCE
Indicate the formal education, certification or license(s) required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible).
BS and 2 - 5 yrs exp., or MS and 1-2 yrs exp. Engineering discipline or equivalent experience. Biomedical, Materials, Mechanical, Industrial Engineering degree preferred.
TECHNICAL SKILLS REQUIREMENTS
Indicate the technical skills required and/or preferred, as applicable.
Preferred: Systems Engineering experience and working knowledge of medical plastics. Experience with DOORS requirements management software.
Required: Understanding of FDA and EU regulations. Working knowledge of CFR 820.30 and medical device experience of the following design control deliverables:
• Design Controls and ISO 14971
• Hazard Analysis
• Use FMEA, design FMEA, process FMEA
• User Requirements
• Product Requirements: Design Input and Design Output
• Traceability Matrix
• Knowledge of Design Verification and validation
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